A Phase 4 interventional study of Deep to Moderate NMB and Moderate to Deep NMB in Cholecystitis, Endometriosis and Bowel Obstruction, sponsored by Stony Brook University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-08.
Sponsored by Stony Brook University · Phase 4, Interventional, and Treatment
This is a two period cross-over study randomizing patients undergoing laparoscopic surgery into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "moderate blockade" and, group 2 in which patients receive "moderate neuromuscular blockade" in the beginning portion of their laparoscopic surgery followed by a period of "deep blockade". The deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to reverse the block at the end of surgery in order to obtain optimal extubating conditions.
Neuromuscular blockade (NMB) is frequently utilized in laparoscopic procedures to improve surgical conditions by relaxing the abdominal muscles and thus facilitating insufflation with carbon dioxide to optimize surgical view. Increased airway pressures can lead to an increase in alveolar and perivascular edema, a decline in dynamic lung compliance and hypoxemia.
Several studies have investigated surgical view under deep vs. moderate neuromuscular blockade. Literature supports deep neuromuscular blockade providing better operating conditions/view by a surgeon and low airway pressures but, potentially, longer duration to extubation and worse respiratory mechanics at the end of anesthesia versus moderate neuromuscular blockade which shows worse operating conditions/view by a surgeon and worse airway pressures but possibly shorter duration to extubation and better respiratory mechanics at the end of anesthesia.
Thus, there is clearly equipoise with regard to the comparative effectiveness of deep vs medium NMB. Therefore, this study is designed to ascertain if a deep neuromuscular block will decrease the airway pressures in patients undergoing laparoscopic procedures compared to those under a moderate block. A reduction in airway pressures may lead to a decrease in the complications associated with elevated airway pressures including hypoxemia, total static lung compliance, alveolar edema, and long term morbidity. Additionally, the study aims to determine if time from administration of sugammadex to reversal is different between patients that have a moderate NMB as compared to a deep NMB.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 79 is close to the median of 86 across 167 interventional studies indexed under Cholecystitis.
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Of its 22 completed or terminated interventional studies of FDA-regulated products, 10 (45%) have results posted.
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Exclusion Criteria:
This group will undergo deep neuromuscular blockade, defined as post tetanic count (PTC) of 1 to 2, in the beginning portion of the surgery followed by a period of moderate blockade.
Procedure: Deep to Moderate NMB · Drug: Rocuronium
This group will undergo moderate neuromuscular blockade, defined as 1-2 twitches, in the beginning portion of the surgery followed by a period of deep blockade.
Procedure: Moderate to Deep NMB · Drug: Rocuronium
Rocuronium infusion will be paused and the Train of Four (TOF) monitor will be set to every 1-2 min. Once the patient has achieved a "moderate" NMB state (one to two twitches), the infusion of the muscle relaxant will be resumed at a low dose to maintain the patient at this level of blockade.
Rocuronium infusion will be increased in increments of 0.1-0.2 mg/kg/hr. and the TOF monitor will be set to every 1-2 min. Once the patient has no twitches and a PTC of 0-1 ("deep" NMB) the infusion will be adjusted to maintain the patient at this level of NMB.
Peak Airway Pressures
To determine if a deep NMB can lead to lower peak airway pressures in patients undergoing laparoscopic procedures when compared to a moderate NMB
Time frame: Intra-operative, from intubation time to extubation time
Abdominal Insufflation Pressure
To compare surgical operating condition by Abdominal Insufflation Pressure in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB
Time frame: Intra-operative, from intubation time to extubation time
Surgical Rating Scale
To compare surgical operating condition by Surgical Rating Scale (SRS) in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB Surgical Rating Score scores are on a 1-5 scale with 1 = extremely poor conditions, 2 = poor conditions, 3 = adequate conditions, 4 = good conditions, 5= excellent conditions. Higher scores mean a better outcome.
Time frame: Intra-operative, from intubation time to extubation time
| Milestone | Deep to Moderate Neuromuscular Block (NMB) | Moderate to Deep NMB |
|---|---|---|
| Started | 40 | 39 |
| Completed | 29 | 24 |
| Not completed | 11 | 15 |
| Withdrew: Post randomization screen failure | 5 | 9 |
| Withdrew: Nonevaluable data sets | 6 | 6 |
| Milestone | Deep to Moderate Neuromuscular Block (NMB) | Moderate to Deep NMB |
|---|---|---|
| Started | 29 | 24 |
| Completed | 29 | 24 |
| Not completed | 0 | 0 |
To determine if a deep NMB can lead to lower peak airway pressures in patients undergoing laparoscopic procedures when compared to a moderate NMB
| cm H2O | Deep NMB | Moderate NMB |
|---|---|---|
| Mean | 25.5 (23.6 to 30.3) | 28.3 (23.9 to 35.0) |
| Maximum | 28 (24 to 32) | 30 (27 to 36) |
To compare surgical operating condition by Abdominal Insufflation Pressure in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB
| mmHg | Deep NMB | Moderate NMB |
|---|---|---|
| Abdominal Insufflation Pressure | 15 (14.8 to 15.2) | 15 (14.6 to 15.2) |
To compare surgical operating condition by Surgical Rating Scale (SRS) in patients undergoing laparoscopic procedures using deep NMB versus moderate NMB Surgical Rating Score scores are on a 1-5 scale with 1 = extremely poor conditions, 2 = poor conditions, 3 = adequate conditions, 4 = good conditions, 5= excellent conditions. Higher scores mean a better outcome.
| units on a scale | Deep NMB | ModerateNMB |
|---|---|---|
| Surgical Rating Scale | 5 (5 to 5) | 5 (5 to 5) |
Collected over Intraoperative (intubation time to extubation time). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Deep NMB | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Moderate NMB | 0/53 (0%) | 0/53 (0%) | 0/53 (0%) |
| Age, Continuous(years) | Deep to Moderate NMB | Moderate to Deep NMB | Total |
|---|---|---|---|
| Mean | 52.8 ± 14.9 | 50.8 ± 15.4 | 51.8 ± 15.15 |
| Sex: Female, Male(Participants) | Deep to Moderate NMB | Moderate to Deep NMB | Total |
|---|---|---|---|
| Female | 17 | 14 | 31 |
| Male | 12 | 10 | 22 |
| Race (NIH/OMB)(Participants) | Deep to Moderate NMB | Moderate to Deep NMB | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 29 | 24 | 53 |
| Procedure(Participants) | Deep to Moderate NMB | Moderate to Deep NMB | Total |
|---|---|---|---|
| General | 26 | 15 | 41 |
| General/Gynecology | 1 | 2 | 3 |
| Gynecology | 2 | 5 | 7 |
| Urology | 0 | 2 | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Fully analyzed results may be shared with Merck Investigator Studies Program personnel after the study has completed
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